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The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.

When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following in degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 -- S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease - defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor.

In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX™ Reconstruction System with the VERTEX™ rod connector. Refer to the VERTEX™ Reconstruction System Package Insert for a list of the VERTEX™ indications of use.

The CD HORIZON® Spinal System consists of a variety of rods, hooks, screws, CROSSLINK® plates, staples, and other connecting components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components.

The CD HORIZON® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The CD HORIZON® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. If necessary, the CD HORIZON® Spinal System can be connected to the VERTEX™ Reconstruction System through a rod connector.

Certain implant components from other Medtronic Sofamor Danek spinal systems can be used with the CD HORIZON® Spinal System. These components include TSRH® rods, hooks, screws, plates, CROSSLINK® plates, connectors, staples and washers; GDLH® rods, hooks, connectors and CROSSLINK® bar and connectors: LIBERTY® rods and screws: DYNALOK PLUS® bolts; and Medtronic Sofamor Danek Multi-Axial rods and screws.

CD HORIZON® hooks are intended for posterior use only. CD HORIZON® staples and CD HORIZON® ECLIPSE® rods and screws are intended for anterior use only. However, for patients of smaller stature. CD HORIZON® 4.5mm rods and associated components may be used posteriorly.

The purpose of this 510(k) submission is to include modified CD HORIZON® hooks to the CD HORIZON® Spinal System.

The provided document is a 510(k) summary for the CD HORIZON® Spinal System from August 2004. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than providing extensive clinical study data with acceptance criteria and performance metrics in the way a PMA submission might.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance against those criteria, sample sizes for test/training sets, expert qualifications, or adjudication methods for a study proving the device meets acceptance criteria.

The core of this 510(k) is the assertion that the modified CD HORIZON® hooks are substantially equivalent to previously cleared CD HORIZON® Spinal System components.

Here's an attempt to address the points based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not define specific acceptance criteria regarding performance metrics (e.g., strength, durability, biological response) for the modified hooks, nor does it report quantitative performance against such criteria in a study. The "performance" being demonstrated is primarily substantial equivalence in design and intended use to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document does not describe a clinical or preclinical "test set" with a specified sample size for proving performance against acceptance criteria. The submission is based on demonstrating substantial equivalence through design comparisons and existing predicate device data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This type of information would be relevant for studies evaluating diagnostic or prognostic devices where expert consensus is needed to establish ground truth. This document pertains to a spinal implant system where ground truth would relate to material properties, biomechanical performance, and clinical outcomes, which are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. As no specific test set or expert evaluation is detailed for performance against acceptance criteria, an adjudication method is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. MRMC studies are typically used to evaluate diagnostic imaging devices or software. This document is for a spinal implant system.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This document is for a physical medical device (spinal implant), not a software algorithm.

7. Type of Ground Truth Used

Not applicable. For a spinal implant, "ground truth" would typically relate to the physical properties of the materials, the biomechanical stability of the construct, and ultimately, clinical safety and effectiveness. However, no specific studies detailing these "ground truths" and the device's performance against them are presented in this 510(k) summary. The submission relies on the concept of substantial equivalence, meaning it's similar enough to devices already deemed safe and effective.

8. Sample Size for the Training Set

Not applicable. This document does not refer to a "training set" as it would be understood in the context of machine learning or deep learning model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set is described (see point 8), the establishment of its "ground truth" is also not discussed.

Summary of the Study Discussed in the Document:

The primary "study" or justification presented in this 510(k) summary is a demonstration of substantial equivalence of the modified CD HORIZON® hooks to previously cleared predicate devices.

• Evidence presented: "Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K041460 and K031655."
• Approval: The FDA reviewed this documentation and concluded that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

This means the submission relies on the safety and effectiveness profile of existing, cleared devices rather than providing new, comprehensive performance data for the specific modification.

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